MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-PLYMOUTH) ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number	C407699
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the deployment of portico tavi, it was noted that the yellow cap on top of the 19f ultimum hemostasis introducer was detached and blood was leaking from that site.The introducer was able to be manipulated in order to complete the procedure.A higher blood loss than normal was experienced by the patient, but no interventions were needed to replenish the loss of blood.
Additional Manufacturer Narrative
One 19f ultimum ev introducer sheath was received for evaluation.The dilator was also returned.The yellow hemostasis cap was no longer attached to the hemostasis body.The hemostasis seal was located inside the hemostasis cap.No other visual anomalies were noted.The introducer was examined and found no evidence that the device was welded; the weld between the cap and hub joint is not visible.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8354857
• Report Number: 3005334138-2019-00092
• Device Sequence Number: 2370647
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: C407699
• Device Catalogue Number: C407698
• Device Lot Number: 6521297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR